A Phase 3 interventional study of Compound Sodium Alginate Double Action Chewable Tablets and Matching placebo tablets in Gastroesophageal Reflux Disease and Dyspepsia, sponsored by Reckitt Benckiser Healthcare (UK) Limited. Completed at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Reckitt Benckiser Healthcare (UK) Limited (part of Reckitt) · Phase 3, Interventional, and Treatment
This study is being conducted to provide evidence that Compound Sodium Alginate Double Action Chewable Tablets are effective in managing the symptoms of heartburn, acid regurgitation and dyspepsia in patients with Gastroesophageal Reflux Disease (GERD).
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's enrollment of 1,107 is above the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Reckitt Benckiser Healthcare (UK) Limited is the lead sponsor of 35 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
Drug: Compound Sodium Alginate Double Action Chewable Tablets
Matching placebo tablets, 2 tablets four times daily
Drug: Matching placebo tablets
2 tablets four times daily
Also known as: Gaviscon Double Action Tablets
2 tablets four times daily
Also known as: Placebo
Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension
The primary study endpoint is the change from baseline in RDQ symptom scores for the GERD dimension (heartburn and regurgitation) after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The RDQ is a 12-item self-administered questionnaire designed to assess the frequency and severity of heartburn, acid regurgitation and dyspepsia symptoms, with a minimum score of 0 and a maximum score of 60, with lower RDQ scores showing an improved outcome. The heartburn and acid regurgitation subscales can be combined into a GERD dimension, which has a minimum score of 0 and a maximum score of 40, with lower RDQ scores showing an improved outcome.
Time frame: 7 days
Change From Baseline in RDQ Scores for the Dyspepsia Dimension
The change from baseline in RDQ symptom scores for the dyspepsia dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The dyspepsia subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
Time frame: 7 days
Change From Baseline in RDQ Scores for the Heartburn Dimension
The change from baseline in RDQ symptom scores for the heartburn dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The heartburn subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
Time frame: 7 days
Change From Baseline in RDQ Scores for the Regurgitation Dimension
The change from baseline in RDQ symptom scores for the regurgitation dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The regurgitation subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
Time frame: 7 days
Overall Treatment Evaluation (OTE) as a Measure of Patient Responsiveness/Satisfaction: Question 1 - Patient's Evaluation of the Change in Symptoms Over the Last 7 Days
Comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit. Question 1 of the OTE assessed how the patients rated their responsiveness/satisfaction on a 15-point scale (from -7 = a very great deal worse to +7 = a very great deal better).
Time frame: 7 days
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
Comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit. Question 2 of the OTE addressed how patients perceived the importance of the change of the clinical status on a 7-point scale (from 1 = not important to 7 = extremely important).
Time frame: 7 days
For Patients With Improvement Only: OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
For patients with improvement only, comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit. Question 2 of the OTE addressed how patients perceived the importance of the change of the clinical status on a 7-point scale (from 1 = not important to 7 = extremely important).
Time frame: 7 days
| Milestone | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets |
|---|---|---|
| Started | 552 | 555 |
| Completed | 531 | 531 |
| Not completed | 21 | 24 |
| Withdrew: Adverse event | 3 | 5 |
| Withdrew: Lack of efficacy | 0 | 3 |
| Withdrew: Withdrawal by subject | 6 | 7 |
| Withdrew: Lost to follow-up | 11 | 9 |
| Withdrew: No further need of investigational product | 1 | 0 |
The primary study endpoint is the change from baseline in RDQ symptom scores for the GERD dimension (heartburn and regurgitation) after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The RDQ is a 12-item self-administered questionnaire designed to assess the frequency and severity of heartburn, acid regurgitation and dyspepsia symptoms, with a minimum score of 0 and a maximum score of 60, with lower RDQ scores showing an improved outcome. The heartburn and acid regurgitation subscales can be combined into a GERD dimension, which has a minimum score of 0 and a maximum score of 40, with lower RDQ scores showing an improved outcome.
| score on a scale | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets |
|---|---|---|
| Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension | -1.27 (-1.37 to -1.16) | -1.06 (-1.17 to -0.95) |
The change from baseline in RDQ symptom scores for the dyspepsia dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The dyspepsia subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
| score on a scale | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets |
|---|---|---|
| Change From Baseline in RDQ Scores for the Dyspepsia Dimension | -0.98 (-1.10 to -0.86) | -0.80 (-0.91 to -0.68) |
The change from baseline in RDQ symptom scores for the heartburn dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The heartburn subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
| score on a scale | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets |
|---|---|---|
| Change From Baseline in RDQ Scores for the Heartburn Dimension | -1.16 (-1.28 to -1.04) | -0.95 (-1.07 to -0.83) |
The change from baseline in RDQ symptom scores for the regurgitation dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The regurgitation subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
| score on a scale | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets |
|---|---|---|
| Change From Baseline in RDQ Scores for the Regurgitation Dimension | -1.37 (-1.48 to -1.26) | -1.16 (-1.27 to -1.05) |
Comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit. Question 1 of the OTE assessed how the patients rated their responsiveness/satisfaction on a 15-point scale (from -7 = a very great deal worse to +7 = a very great deal better).
| Participants | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets |
|---|---|---|
| -7 = A very great deal worse | 0 | 0 |
| -6 = A great deal worse | 0 | 1 |
| -5 = A good deal worse | 0 | 0 |
| -4 = Moderately worse | 0 | 3 |
| -3 = Somewhat worse | 6 | 2 |
| -2 = A little worse | 3 | 10 |
| -1 = Almost the same, hardly any worse at all | 2 | 4 |
| 0 = No change | 41 | 64 |
| 1 = Almost the same, hardly any better at all | 32 | 47 |
| 2 = A little better | 85 | 106 |
| 3 = Somewhat better | 87 | 89 |
| 4 = Moderately better | 88 | 72 |
| 5 = A good deal better | 116 | 92 |
| 6 = A great deal better | 53 | 33 |
| 7 = A very great deal better | 23 | 13 |
| Missing | 0 | 1 |
Comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit. Question 2 of the OTE addressed how patients perceived the importance of the change of the clinical status on a 7-point scale (from 1 = not important to 7 = extremely important).
| Participants | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets |
|---|---|---|
| 1 = Not important | 19 | 25 |
| 2 = Slightly important | 31 | 51 |
| 3 = Somewhat important | 48 | 44 |
| 4 = Moderately important | 55 | 49 |
| 5 = Important | 174 | 153 |
| 6 = Very important | 138 | 118 |
| 7 = Extremely important | 31 | 32 |
| Missing | 40 | 65 |
For patients with improvement only, comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit. Question 2 of the OTE addressed how patients perceived the importance of the change of the clinical status on a 7-point scale (from 1 = not important to 7 = extremely important).
| Participants | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets |
|---|---|---|
| 1 = Not important | 18 | 22 |
| 2 = Slightly important | 29 | 48 |
| 3 = Somewhat important | 47 | 40 |
| 4 = Moderately important | 55 | 49 |
| 5 = Important | 169 | 151 |
| 6 = Very important | 136 | 112 |
| 7 = Extremely important | 30 | 30 |
Collected over Up to 8 days, from after the first dose of IMP until no later than the day of the last dose of IMP +1. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sodium Alginate Double Action Chewable Tablets | 0/549 (0%) | 1/549 (0.2%) | 0/549 (0%) |
| Matching Placebo Tablets | 0/550 (0%) | 0/550 (0%) | 0/550 (0%) |
| Event | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets |
|---|---|---|
| Gastro-oesophageal reflux diseaseGastrointestinal disorders | 1/549 | 0/550 |
Eight subjects (3 in the Sodium Alginate Double Action Chewable Tablets group and 5 in the matching placebo tablets group) were randomized in the study, but not treated, and therefore not included in the safety population, from which baseline data were drawn.
| Age, Continuous(Years) | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets | Total |
|---|---|---|---|
| Mean | 45.0 ± 11.81 | 44.8 ± 11.84 | 44.9 ± 11.82 |
| Sex: Female, Male(Participants) | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets | Total |
|---|---|---|---|
| Female | 280 | 262 | 542 |
| Male | 269 | 288 | 557 |
| Race/Ethnicity, Customized(Participants) | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets | Total |
|---|---|---|---|
| Caucasian | 1 | 0 | 1 |
| Asian | 548 | 550 | 1098 |
| Afro-Caribbean | 0 | 0 | 0 |
| Other | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets | Total |
|---|---|---|---|
| China | 549 | 550 | 1099 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2013 to primary completion in May 2014, 11 months.
Results were first posted in Mar 2025, 10 years 10 months after primary completion.
Of 20 phase 3 interventional studies under Gastroesophageal Reflux, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 49. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Reckitt Benckiser Healthcare (UK) Limited →